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Prenate Pixie

Generic name: prenatal vitamin
Dosage form: softgel

Medically reviewed by Drugs.com. Last updated on Jan 1, 2021.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Rx Only

DESCRIPTION: Prenate Pixie® is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is purple in color, opaque, and imprinted with “PIX”.

OTHER INGREDIENTS: Capsule gelatin (gelatin, glycerin, purified water, titanium dioxide, FD&C red #40, caramel, and FD&C blue #1), palm shortening, soy lecithin, and yellow beeswax. Prenate Pixie® contains fish oil and soy.

INDICATIONS: Prenate Pixie® is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.

WARNING: Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.

PRECAUTIONS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one softgel daily or as directed by a physician.

HOW SUPPLIED: Bottles of 30 softgels (75854-0316-30). The listed product number is not a National Drug Code. Instead, Avion Pharmaceuticals has assigned a product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems.

STORAGE: Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]

THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Sumalate® is a registered trademark of Albion Laboratories, Inc., covered by one or more claims of U.S. Patent Nos. 5,516,925, 6,716,814, 8,007,846, and 8,425,956.

MANUFACTURED FOR:

Avion Pharmaceuticals, LLC
Alpharetta, Georgia 30005

1-888-61-AVION

Rev. 0519-03

CONTRAINDICATIONS: Prenate Pixie® is contraindicated in patients with a known hypersensitivity to any of the ingredients.

75854-0316-30

Prenate Pixie®

Robust Rx Prenatal Vitamin with
11 concentrated nutrients and minerals

in a tiny softgel package

SUGAR FREE

GLUTEN FREE

LACTOSE FREE

Rx Only

Dietary Supplement

30 Softgels

Prenate Pixie
ascorbic acid, biotin, cholecalciferol, cyanocobalamin, folic acid, ferrous asparto glycinate, potassium iodide, pyridoxine hydrochloride, .alpha.-tocopherol acetate, dl-, docusate sodium and blueberry tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:75854-316
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 30 mg
BIOTIN (BIOTIN) BIOTIN 75 ug
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 500 [iU]
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 13 ug
FOLIC ACID (FOLIC ACID) FOLIC ACID 400 ug
FERROUS ASPARTO GLYCINATE (FERROUS CATION) FERROUS CATION 10 mg
POTASSIUM IODIDE (IODIDE ION) IODIDE ION 150 ug
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 5 mg
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 10 [iU]
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 200 mg
BLUEBERRY (BLUEBERRY) BLUEBERRY 5 mg
LEVOMEFOLIC ACID (LEVOMEFOLIC ACID) LEVOMEFOLIC ACID 600 ug
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
YELLOW WAX
LECITHIN, SOYBEAN
CORN OIL
WATER
TITANIUM DIOXIDE
FD&C RED NO. 40
CARAMEL
FD&C BLUE NO. 1
GELATIN
Product Characteristics
Color purple Score no score
Shape OVAL Size 22mm
Flavor Imprint Code PIX
Contains
Packaging
# Item Code Package Description
1 NDC:75854-316-30 30 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/15/2014
Labeler - Avion Pharmaceuticals, LLC (040348516)
Establishment
Name Address ID/FEI Operations
Avion Pharmaceuticals, LLC 040348516 manufacture(75854-316)
Avion Pharmaceuticals, LLC

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